Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of combivent® aerosol and spacer, in adult patients with moderate to severe asthma crisis

Conditions: Asthma

Summary: study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol sulfate (120 mcg) + ipratropium bromide (20mcg) (combivent® mdi) in aerosol plus spacer in adult patients with moderate-to-severe asthma crisis who arrived at the emergency room.


Eligibility criteria:
inclusion criteria: * male or female patients with a diagnosis of asthma according to the american thoracic society (ats) presenting at the emergency room with an acute moderate and/or severe asthma attack * patients aged between18 to 40 years * patients able to perform spirometry (pefr and fev1) * pefr \ 25 % of predicted normal value or a fev1 \<= 60% of predicted normal value * patients able to sign witnessed informed consent exclusion criteria: * patients with very severe or life threatening obstruction, manifested by: * cyanosis of tongue and lips * confusion, drowsiness, coma or exhaustion * silent chest on auscultation or weak respiratory effort * pefr \< 25% the predicted normal value * bradycardia (of less 60 beats/min) * patients with a smoking history of more than 10 pack/years * patients with chronic obstructive pulmonary disease (copd) * patients on treatment for or suspected as having glaucoma * patients with uncontrolled hypertension * patients with known allergy or contra-indications to either salbutamol, ipratropium or hydrocortisone or their excipients * female patients known or suspected to be pregnant or nursing * patients known or suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum * patients with a history of chest surgery * patients with other respiratory conditions if diagnosed. these included pulmonary fibrosis, bronchiectasis, cystic fibrosis, pulmonary tuberculosis, pulmonary complications of aids, lung cancer * patients requiring drugs for the treatment of the acute asthma attack other than the study drug, hydrocortisone or oxygen * patients who have previously recruited into this study * patients who have been on other investigational drugs within three months prior to study entry * patients with acute myocardial infarction, pulmonary edema or other life threatening disease, which in the judgment of the er (emergency room) physician precluded entry into the study * patients with obvious or previous diagnosed serious hepatic or renal impairment or bladder neck obstruction
qualitative study of topical mesalamine adherence in patients with ulcerative colitis(uc)

Conditions: Ulcerative Colitis

Summary: the purpose of this protocol is: 1. to quantify the prevalence of adherence to topical mesalamine in patients with uc 2. to describe the determinants of medication adherence in patients with uc prescribed topical mesalamine

patient adherence with topical mesalamine is low. behavioral and psycho-social barriers to topical mesalamine adherence exist in patients with uc. these factors can be identified using qualitative testing in order to develop and design appropriate behavioral interventions to reduce non-adherence. the investigators will undertake an observational study of medication persistence in 100 patients in the bidmc clinic, "persistence cohort". persistence will be measured using 12-month pharmacy refill data. the investigators will also employ a qualitative research design with discrete choice modeling in two phases: phase i - initial interviews with 10 patients and phase ii - focus groups (2) with 5 patients each.

Eligibility criteria:
inclusion criteria: * must have ulcerative colitis diagnosed by a doctor at least 1 month prior to study participation * must be prescribed topical mesalamine (e.g. rowasa enemas or canasa suppositories) by a doctor * must be receiving care at beth israel deaconess medical center exclusion criteria: * no diagnosis of ulcerative colitis * no prescription for topical mesalamine * not receiving care at beth israel deaconess medical center

Keywords: ulcerative colitis
evaluating central line hub contamination using a novel capping device

Conditions: Catheter-related Bloodstream Infection Due to Central Venous Catheter

Summary: excelsior medical has developed swabcap™, a luer access valve disinfection cap. the swabcap™ provides passive disinfection of valve top and threads without activating the luer access valve. this product promotes technique standardization and compliance in cleansing of the luer access valve prior to access. it acts as a physical barrier from touch and airborne contamination for up to 96 hours. this product has been endorsed and will be adopted for use at northshore university healthsystem as a quality improvement initiative. this research study protocol is designed to confirm the anticipated benefit of this change in practice at northshore during the planned implementation and use. if the product performs as it has been designed to, the baseline rate of hub and subsequently intraluminal contamination will be diminished, thereby protecting patients with central lines from bloodstream infections due to contaminated hubs.


Eligibility criteria:
inclusion criteria: * adult patients with peripherally inserted central catheters (picc) inserted during their index hospitalization plus 5 or more consecutive picc line days were consented and enrolled. exclusion criteria: * minors and adult inpatients without piccs or with piccs for \< 5 days
a clinical trial to evaluate the reversibility of abacavir/lamivudine/dolutegravir cns-related neurotoxicity after switching to tenofovir/alafenamide/emtricitabine/darunavir/cobicistat (taf/ftc/drv/c)

Conditions: HIV Infections

Summary: a phase iv, multicentre, randomised, open-label, pilot clinical trial to evaluate the reversibility of abacavir/lamivudine/dolutegravir ( abc/3tc/dtg) cns-related neurotoxicity after switching to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (taf/ftc/drv/c)

the investigators estimate that 55 participants will need to be included per group, 110 patients in total, to demonstrate the benefit of switching abc/3tc/dtg to taf/ftc/drv/c

Eligibility criteria:
inclusion criteria: * patient ≥ 18 years of age diagnosed with hiv using conventional serology techniques. * current antiretroviral therapy with abc/3tc/dtg for at least 4 weeks. * hiv viral load \< 50 copies/ml for at least 24 weeks prior to signing the consent form (confirmed by two assays at least 12 weeks apart with viremia \< 50 copies/ml between both). if the patient has a recent routine blood test available (≤ 4 weeks) that includes determining hiv viral load, these results may be used for the screening visit. if this test is not available, or the test is more than four weeks old, viral load will be determined on the day of screening in order to confirm that the patient meets this criterion. * a positive screening test for sleep disorders detected using the sleep quality index (pittsburgh ). exclusion criteria: * determination of at least one hiv viral load ≥ 50 copies/ml in the last 12 weeks. * allergy, intolerance or existence of resistance mutations to any of the components of taf/ftc/drv/c. * history of active cns infections. * active psychosis, major depression with psychotic symptoms or autolytic ideation. * dementia or mental retardation. * drug use with a diagnosis of abuse or dependence according to dsm-5 criteria. * illnesses that may interfere with the study procedures. * inability to complete any of the study procedures. * pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method. * patient with documented intolerance or hypersensitivity to the study medication, or who has a contraindication to use it, according to the technical data sheet
the role of 1.5-anhydro-d-glucitol as clinical biomarkers of hypoglycemia in patients with diabetes

Conditions: Type 2 Diabetes Mellitus With Hypoglycemia

Summary: the purpose of this study is to evaluate the usefulness of plasma 1,5-anhydro-d-glucitol (1,5-ag) as a novel surrogate marker of hypoglycemia

we enrolled well controlled diabetes patients who had hypoglycemic event at least one time more. all patients assess the risk of severe hypoglycemia and hypoglycemic unawareness using hypoglycemic awareness questionnaires (hypo score). the patients who are treated with insulin agent were inserted sensor of continuous glucose monitoring systems under the skin during three days. we were analysed the correlation between 1,5-anhydro-d-glucitol and hypo score.

Eligibility criteria:
inclusion criteria: * patients attending outpatients of department of endocrinology and metabolism, seoul national university hospital .(hba1c \<8%) * the patients who treated with insulin or sulfonylureas at least 3month period * in case fo sulfonylurea user, hba1c was restricted under 8% * the patients who had hypoglycemic event at least 3 months * who has can be survey questionnaire * who can insert continuous glucose monitoring system exclusion criteria: * renal dysfunction patients * hepatic dysfunction patients * who has any kind of diseases, operations, medical treatments that can affect glucose levels

Keywords: 1,5-anhydro-d-glucitol, hypoglycemia, surrogate marker
a study of solifenacin succinate compared to tolterodine in patients with overactive bladder

Conditions: Overactive Bladder

Summary: the purpose of this study is to ascertain the clinical results of solifenacin succinate of piii study conducted in the original country using korean patients with an overactive bladder.


Eligibility criteria:
inclusion criteria: * symptoms of overactive bladder * must be able to complete the micturition diary exclusion criteria: * pregnant or lactating * clinically significant outflow obstruction * significant post void residual urine * significant stress incontinence * urinary tract infection * chronic inflammation * bladder stones * previous pelvic radiation therapy * previous or current malignant disease of the pelvic organs * uncontrolled narrow angle glaucoma * urinary or gastric retention * electrostimulation therapy * bladder training * diabetic neuropathy

Keywords: solifenacin tolterodine randomized controlled trial double-blind method
cryoballon versus radiofrequency ablation for persistent atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: a randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (rf) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (af). there is a growing amount of evidence suggesting that cryoballoon ablation is highly effective also in non-paroxysmal atrial fibrillation. the iron-ice trial will evaluate the effect of cryoballoon af ablation in patients with short-term persistent af.


Eligibility criteria:
inclusion criteria: 1. candidates for af ablation based on af that is symptomatic and refractory to at least one antiarrhythmic medication. 2. patients presenting with persistent af with af duration \< 2 years scheduled to undergo a pvai procedure 3. age range of 18 - 85 years 4. patients with already implanted devices with af detection capabilities (for clinical indications): ilr implanted in the same hospital stay or within 6 months before the ablation or patients with an dual chamber pm, icd or crtd and an existing functional atrial lead. 5. patients must be able and willing to provide written informed consent to participate in the clinical trial. exclusion criteria: * congenital heart disease, age younger than 18 years, significant valve disease, la size \>55 mm, and severe heart failure (ejection fraction \< 30% and/or new york heart association class iv). * presence of a mechanical prosthetic valve. * secondary causes of atrial fibrillation * documented intra-atrial thrombus or another abnormality which precludes catheter introduction. * social factors that would preclude follow up or make compliance difficult.- * patients who are or may potentially be pregnant previous left atrial catheter ablation or maze procedure.

Keywords: persistent atrial fibrillation catheter ablation
spiritual intervention for persons with depression

Conditions: Depression

Summary: mental health is an integral part of health and depression has become a common and serious mental disorder. the research study aims to explore the effectiveness of spiritual intervention in persons with depression.

this study aims to develop a community-oriented spiritual intervention programme that focuses on connectedness and to explore its effectiveness in persons with depression. objectives: 1. to evaluate the effect of this spiritual intervention on reducing depressive symptoms. 2. to evaluate the effect of spiritual intervention on enhancing hope, meaning in life, self-esteem, and social support. 3. to examine the moderatioon effect of demographic variables on the intervention effect in reducing the depressive and anxiety symptoms, and ennhancing hope, meaning in life, self-esteem, and social support. 4. to examine participant's perspectives on the healing mechanisms of the intervention. the study is conducted as a randomized-controlled trial using a wait-list control group for comparison. the wait-list control group will receive the intervention after the completion of the post-questionnaire. the intervention is an 8 session weekly programme. each weekly session is around 2 hours in length and the content is as below: 1. spirituality, mental health and depression 2. connectedness 3. forgiving and freedom 4. suffering and transcendence 5. hope 6. gratitude 7. relapse prevention and spiritual growth 8. wrap-up and celebration

Eligibility criteria:
inclusion criteria: * hong kong chinese residents who can communicate in cantonese; * religious or non-religious but have no objection to christian faith rituals; * screening by phq-9 with score of 5-14 out of 27; and * willing to give informed consent and comply with the trial protocol. exclusion criteria: * receiving any form of psychotherapy in the past 3 months; * significant cognitive impairment that is difficult to follow instructions; * lifetime history of psychosis that make the person unable to understand and follow instructions; * strong suicidal risk as rated by phq-9 item on suicide (score equal or more than 2), those with severe depression and strong suicidal ideas will be referred to seek professional help; and * adjustment of medication (antidepressant) within the past 3 months.

Keywords: spiritual intervention depression christian connectedness randomized wait-list community
long-term follow up helicobacter pylori reinfection rate after second-line treatment: bismuth-containing quadruple therapy versus moxifloxacin-based triple therapy

Conditions: Helicobacter Infections

Summary: patients who had failed previous h. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (ebmt) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (mea). at four weeks after completion of eradication therapy, h. pylori tests were performed with 13c urea breath test (ubt) or invasive tests (giemsa histology, clo test, and culture). in patients who maintained continuous h. pylori negativity for the first year after eradication therapy, h. pylori status was assessed every year. for the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.


Eligibility criteria:
inclusion criteria: * patients were considered persistent h. pylori infection if 13c-urea breath test (ubt) or invasive h. pylori test (giemsa histology, clo test, culture) were positive despite ppi-based triple therapy. exclusion criteria: * patients were excluded from the study if they had a history of renal or hepatic impairment, previous gastric surgery, pregnancy or lactation, therapy with steroids or non-steroidal anti-inflammatory drugs, or therapy with a proton pump inhibitor (ppi) or antibiotics within four weeks of entry.
efficacy study image guided, auto-targeted neurostimulation for the treatment of non-specific low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is: * initial evaluation of the clinical effectiveness of image guided transcutaneous electrical stimulation (tens) device for treatment of non-specific low back pain. * to assess the tolerability and acceptability of the device by the caregiver ("user friendly"). * to evaluate patients' tolerance by monitoring side effects and tolerability during treatment.

transcutaneous electrical nerves stimulation (tens) devices are a drug-free alternative for managing pain. for the past thirty years, doctors have been prescribing fda approved tens worldwide as an effective way to relieve pain. tens device currently utilized includes a variety of types of devices and pulse modulations. most of these devices are applied on large surface areas, and are designed to block the pain signal (gate mechanism) to the brain. others manual tens devices are applied to small surface areas to stimulate peripheral nerve ends, and by that causing the release of endorphins with a significantly superior clinical outcome. such treatments are time consuming and cumbersome and requires previous knowledge of location of nerve ends. a novel device capable of scanning a large skin surface area, automatically locating nerve ends responsible for pain relief by utilizing skin impedance measurements and image processing with anatomical matching will be tested for stimulating these peripheral nerve ends (nema-st, nervomatrix ltd., netanya, israel). for this purpose an open study to initially evaluate safety and efficacy of the intervention is designed. 20 patients will undergo 2 treatment sessions per week for a period of 4 weeks, while maintaining their pain relief medication treatment regime.

Eligibility criteria:
inclusion criteria: * non-specific low back pain persisted at least 1 month and no longer than 12 month before the study * patients must have a baseline score\>40 mm on the vas pain scale * if taking analgesics, patients must agree to maintain a steady regimen for the duration of the study. * able to provide written and verbal informed consent. exclusion criteria: * sciatica * diagnosed spinal stenosis * back pain potentially attributable to specific underlying diseases or conditions (e.g. pregnancy, metastatic cancer, spondylolisthesis, fractured bones, dislocated joints, disc eruption). * unstable medical or severe psychiatric conditions or dementia. * previous back surgery * physically unable to undergo treatment * patients receiving workers compensation or those involved in litigation * minimal pain - less than 40mm score on vas scale * history of pacemaker , implantable devices, history of cardiac arrhythmias * allergy or intolerance to adhesive materials * clinical evidence of cardiovascular, pulmonary, renal, hepatic, neurological , hematological or endocrine abnormalities.
snaps breast cancer patient study breast cancer patients

Conditions: Breast Cancer; Breast Cancer Female

Summary: differential immunogenomic signatures from peripheral blood cd14 (phagocytic) and cd2 (non-phagocytic) cells have been associated with multiple cancers and disease states. in particular several large clinical studies at immunis.ai have demonstrated robust immunogenomic signatures in early-stage prostate cancer. immunis.ai therefore hypothesizes that a peripheral blood immunogenomic signature will identify patients with various stages of breast cancer from healthy negative controls.

efficient next generation rna sequencing platforms have allowed for whole genome expression profiling of individual populations of immune cells as a novel means of searching for patterns of gene expression to aid in the identification of meaningful signals unique to various disease states. single cell sequencing techniques have provided additional information useful in deconvolution strategies applied to model development on purified populations of immune cells. recent interest in peripheral leukocyte subset gene expression profiles suggests that diagnostic information for many disorders may be contained therein. mononuclear phagocytic cells including the various cd14+ subsets have been studied extensively in various disease states including some solid tumors. previous large clinical studies at immunis.ai have determined that transcriptomic profiles of cd14+ cell populations subtraction normalized from cd2+ cell populations were associated with aggressive disease phenotypes such as prostate cancer. tumor heterogeneity, multifocality, and oligoclonality have been a significant barrier to development of meaningful tissue based multigene signatures for predicting cancer biologic behavior. the findings at immunis.ai strongly suggest that analysis of rna expression data from the body's immune surveillance cells has the potential to summarize the entire heterogeneous tumor. the investigators believe that the cd14/cd2 log ratio can be understood as a subtraction normalization of gene expression which yields superior signal of early-stage cancer.

Eligibility criteria:
inclusion criteria: * patients \> 18 yrs of age. * patients diagnosed with stage i-iv breast cancer, who have not begun definitive therapy. * patients undergoing screening mammograms for breast cancer. exclusion criteria: * patients with a history of a different cancer within the previous 3 years (except non melanoma skin cancer). * any prior treatment (surgery, chemo, hormonal, radiation, biologics, etc.) for current cancer. * any biopsy which resulted in the entire tumor tissue being removed. * history of previous breast cancer. * patients unable to provide informed consent. * patients with an abnormal screening mammogram. * patients whose hormone receptor and/or her2 status are not available.

Keywords: breast cancer immunogenomics